EnteroBiotix Completes EBX-102-02 Phase 2 Recruitment for IBS

On November 18, 2024, EnteroBiotix Limited, a clinical-stage biotechnology company specializing in microbiome therapeutics, announced the successful completion of patient recruitment for its Phase 2 TrIuMPH trial. This trial focuses on assessing the safety, tolerability, and effectiveness of EBX-102-02, EnteroBiotix's leading asset, for treating Irritable Bowel Syndrome (IBS).

The TrIuMPH trial is a meticulous, randomized, double-blind, placebo-controlled study that enrolled a total of 122 patients across two sites in the United Kingdom. These participants, who were diagnosed with severe constipation-predominant IBS (IBS-C) or diarrhea-predominant IBS (IBS-D) using Rome IV criteria, were randomly assigned in a 2:1 ratio to receive either EBX-102-02 or a placebo. The treatment was administered at two different timepoints, one week apart, followed by a six-week monitoring period.

The primary goal of this study is to evaluate the safety and tolerability of EBX-102-02 in patients suffering from severe IBS. Secondary goals include examining the drug's effectiveness, changes in gut microbiome composition and function, and relevant biomarkers.

Dr. James McIlroy, the CEO of EnteroBiotix, expressed his gratitude to the trial participants and investigators for their swift enrollment, noting that this milestone was achieved ahead of schedule. He emphasized that the rapid recruitment reflects patient interest and the critical need for innovative IBS therapies that address microbiome imbalances.

EnteroBiotix is dedicated to developing advanced therapies for gastrointestinal and hepatic diseases. The company's treatments incorporate highly diverse ecosystems of microorganisms, stabilized using proprietary platform technology, aimed at enhancing gut health by augmenting the microbiome.

Recently, EnteroBiotix completed a Phase 1b clinical study of its full-spectrum product EBX-102 in patients with liver cirrhosis. This study demonstrated proof-of-principle across multiple microbiome assessments, inflammatory biomarkers, and clinical evaluations, supporting the ongoing development of EBX-102 as a pioneering microbial therapy for liver disease.

EBX-102-02 is a next-generation, full-spectrum drug candidate containing highly diverse microbial ecosystems and key functional groups that help restore and strengthen the microbiome. This drug is presented in an easy-to-take capsule form with proven stability at ambient temperature.

The TrIuMPH trial, which stands for "Treating IBS with an Intestinal Microbiota Product for Health," is a well-designed, randomized, double-blind, placebo-controlled Phase 2 study aimed at evaluating the safety and tolerability of EBX-102-02 in IBS patients.

A total of 122 participants with IBS were recruited for the TrIuMPH trial at two different sites. Among them, 62 participants with constipation-predominant IBS (IBS-C) and 60 participants with diarrhea-predominant IBS (IBS-D) were administered EBX-102-02 or a matching placebo and monitored for six weeks.

Irritable Bowel Syndrome (IBS) is a chronic, relapsing functional gastrointestinal disorder characterized by various symptoms such as chronic abdominal pain, cramping, bloating, and changes in bowel movements, which can include constipation, diarrhea, or both. It is estimated that up to one in eight people experience IBS-type symptoms, with an approximately equal distribution between those with constipation-predominant IBS (IBS-C) and those with diarrhea-predominant IBS (IBS-D). In the United States, direct medical costs associated with IBS are estimated to be as high as $10 billion annually, with indirect costs reaching up to $20 billion.

The Functional Gut Clinic (FGC), the UK's leading independent provider of gastrointestinal physiology testing and diagnostics, collaborated on this study. Established in 2013, FGC offers both private and NHS services and is the only independent GI physiology clinic in the UK accredited by IQIPS/UKAS and the Care Quality Commission (CQC). FGC has an extensive R&D and clinical trials portfolio dedicated to designing and testing future digestive health tests and treatments.